Intended Use; General Safety Instructions; Product Selection - Ossur PRO-FLEX XC Gebrauchsanweisung

ENGLISH
Medical Device
DESCRIPTION
The device is a prosthetic foot with integrated male pyramid. It is
composed of a dual and bottom blade secured using heel bolts. The
bottom blade features a sandal toe and a full length composite blade.
The device consists of the following components (Fig. 1):
A. Male Pyramid Adapter
B. Pyramid Housing
C. Pyramid Cover
D. Upper C Blade
E. Lower C Blade
F. Bottom Blade
G. Bottom Blade Bolts
H. Drop Toe
The device must be used with a Foot Cover and a Spectra Sock.

INTENDED USE

The device is intended as a part of a prosthetic system that replaces the
foot and ankle function of a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional. The device must be fitted and
adjusted by a healthcare professional.
Indications for Use and Target Patient Population
• Lower limb amputation/deficiency
• No known contraindications
The device is for low to high impact use, e.g., walking and occasional
running.

GENERAL SAFETY INSTRUCTIONS

The healthcare professional should inform the patient about everything
in this document that is required for safe use of this device.
Warning: If there is a change or loss in device functionality, or if the
device shows signs of damage or wear hindering its normal functions,
the patient should stop using the device and contact a healthcare
professional.
The device is for single patient use.

PRODUCT SELECTION

Verify that selected variant of the device is suitable for the impact level
and weight limit according to the following table.
Warning: Do not exceed weight limit. Risk of device failure.
Incorrect category selection may also result in poor device function.
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